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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Disconnection (1171); Pumping Stopped (1503); Battery Problem (2885)
Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Cognitive Changes (2551)
Event Date 05/26/2018
Event Type  Injury  
Manufacturer Narrative
Product id: 8709sc, lot# n304083006, implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: n304083006, ubd: (b)(6) 2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving lioresal (2000 mcg/ml, 756 mcg/day) intrathecal drug delivery pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported that premature battery depletion led to a motor stall (pump logs indicated the stall occurred (b)(6) 2018 at 12:07) and baclofen withdrawal symptoms; the elective replacement interval was 2 months. There were no environmental/external/patient factors that may have led or contributed to the issue. The pump started alarming on (b)(6) 2018 in the afternoon; it was reported that it was alarming because it was nearing end of life. The patient began having withdrawal symptoms on (b)(6) 2018, all-over body itching, increased spasticity, and mental status changes. The patient's wife contacted a neurosurgeon who instructed her to take the patient to the emergency room. The patient was admitted to the hospital on the evening of (b)(6) 2018 in baclofen withdrawal, and was placed on a ventilator. The pump replacement surgery occurred the morning of (b)(6) 2018. When removing the 8709sc catheter from the old pump, the sutureless connector portion of the catheter came apart and was replaced. There were no environmental/external/patient factors that may have led or contributed to the issue, and no troubleshooting was done. The pump and catheter were returned to the manufacturer. The patient was exhibited at the end of the case and returned to the neuro intensive care unit for monitoring. The issue was resolved and the patient status was "alive - no injury" at the time of this report. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving lioresal, 1000 at 6. 4 via intrathecal drug delivery pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported that the patient recently had the pump changed due to a "failure". Patient clarified the pump battery was due to be replaced and began beeping a few days prior to replacement procedure. Patient clarified that by pump "failure" he meant the battery reached end of service (eos) and he had withdrawal. They had originally schedule the replacement for (b)(6) 2018 and thought he would be ok but "that wasn't actually true". Patient had the pump replaced on (b)(6) 2018 and stated they did not have new medication to use to fill the new pump so they aspirated the medication out of the old pump and filled the new pump with it. Patient stated his new pump was only half full because of this. Patient stated he was concerned about getting the pump filled. No further complications were reported.
 
Manufacturer Narrative
H3: the pump was returned, and analysis found corrosion/wear/lubrication, and a motor stall due to shaft bearing. The catheter was returned, and analysis found user damage beyond intended reliability. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7549697
MDR Text Key109415906
Report Number3004209178-2018-12039
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
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